EP3548000A4 - PHARMACEUTICAL COMPOSITIONS OF ATROPINE - Google Patents

PHARMACEUTICAL COMPOSITIONS OF ATROPINE Download PDF

Info

Publication number: EP3548000A4
Authority: EP; European Patent Office
Prior art keywords: atropine; pharmaceutical compositions; pharmaceutical; compositions
Prior art date: 2017-05-11
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

Application number

EP18798073.5A

Other languages

German (de)

French (fr)

Other versions

EP3548000B1 (en

EP3548000A1 (en

Inventor

Navneet Puri

Prem Sagar AKASAPU

Irfan A. MOHAMMED

Kumaresh Soppimath

Iouri V. ILITCHEV

Tao Zhang

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Vyluma Inc

Original Assignee

Nevakar Inc

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2017-05-11

Filing date

2018-05-10

Publication date

2019-12-04

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64096170&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP3548000(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2018-05-10 Priority to SI201830521T priority Critical patent/SI3548000T1/en

2018-05-10 Priority to HRP20212019TT priority patent/HRP20212019T1/en

2018-05-10 Priority to EP21205568.5A priority patent/EP3970694A1/en

2018-05-10 Priority to PL18798073T priority patent/PL3548000T3/en

2018-05-10 Priority to RS20211580A priority patent/RS62817B1/en

2018-05-10 Application filed by Nevakar Inc filed Critical Nevakar Inc

2019-10-09 Publication of EP3548000A1 publication Critical patent/EP3548000A1/en

2019-12-04 Publication of EP3548000A4 publication Critical patent/EP3548000A4/en

2021-11-10 Publication of EP3548000B1 publication Critical patent/EP3548000B1/en

2021-11-10 Application granted granted Critical

Status Active legal-status Critical Current

2038-05-10 Anticipated expiration legal-status Critical

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/08—Mydriatics or cycloplegics
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
Epidemiology (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Engineering & Computer Science (AREA)
Ophthalmology & Optometry (AREA)
Inorganic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Bioinformatics & Cheminformatics (AREA)
Organic Chemistry (AREA)
Emergency Medicine (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Oil, Petroleum & Natural Gas (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Peptides Or Proteins (AREA)
Nitrogen Condensed Heterocyclic Rings (AREA)

EP18798073.5A 2017-05-11 2018-05-10 Atropine pharmaceutical compositions Active EP3548000B1 (en)

Priority Applications (5)

Application Number	Priority Date	Filing Date	Title
HRP20212019TT HRP20212019T1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions
EP21205568.5A EP3970694A1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions
PL18798073T PL3548000T3 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions
RS20211580A RS62817B1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions
SI201830521T SI3548000T1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US201762505027P	2017-05-11	2017-05-11
PCT/US2018/032017 WO2018209051A1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions

Related Child Applications (1)

Application Number	Title	Priority Date	Filing Date
EP21205568.5A Division EP3970694A1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions

Publications (3)

Publication Number	Publication Date
EP3548000A1 EP3548000A1 (en)	2019-10-09
EP3548000A4 true EP3548000A4 (en)	2019-12-04
EP3548000B1 EP3548000B1 (en)	2021-11-10

Family

ID=64096170

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
EP18798073.5A Active EP3548000B1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions
EP21205568.5A Pending EP3970694A1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions

Family Applications After (1)

Application Number	Title	Priority Date	Filing Date
EP21205568.5A Pending EP3970694A1 (en)	2017-05-11	2018-05-10	Atropine pharmaceutical compositions

Country Status (23)

Country	Link
US (14)	US10251875B2 (en)
EP (2)	EP3548000B1 (en)
JP (5)	JP6557379B2 (en)
KR (1)	KR102281667B1 (en)
CN (1)	CN110621298B (en)
AU (1)	AU2018265257B2 (en)
CA (1)	CA3063228C (en)
CL (1)	CL2019003228A1 (en)
CO (1)	CO2019012893A2 (en)
CY (1)	CY1124880T1 (en)
ES (1)	ES2901140T3 (en)
HR (1)	HRP20212019T1 (en)
HU (1)	HUE056595T2 (en)
LT (1)	LT3548000T (en)
MX (1)	MX392558B (en)
PH (1)	PH12019502701A1 (en)
PL (1)	PL3548000T3 (en)
PT (1)	PT3548000T (en)
RS (1)	RS62817B1 (en)
RU (1)	RU2745603C1 (en)
SG (1)	SG11201910085UA (en)
SI (1)	SI3548000T1 (en)
WO (1)	WO2018209051A1 (en)

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US10154923B2 (en)	2010-07-15	2018-12-18	Eyenovia, Inc.	Drop generating device
WO2016172712A2 (en)	2015-04-23	2016-10-27	Sydnexis, Inc.	Ophthalmic composition
US9421199B2 (en)	2014-06-24	2016-08-23	Sydnexis, Inc.	Ophthalmic composition
US11052094B2 (en)	2015-05-29	2021-07-06	Sydnexis, Inc.	D2O stabilized pharmaceutical formulations
SG11201809822SA (en) *	2016-05-25	2018-12-28	Singapore Health Serv Pte Ltd	Atropine-containing aqueous composition
MX392558B (en)	2017-05-11	2025-03-24	Vyluma Inc	Atropine pharmaceutical compositions
CN115300226A (en)	2017-06-10	2022-11-08	艾诺维亚股份有限公司	Apparatus for delivering a volume of fluid to an eye
US11554115B2 (en) *	2018-03-14	2023-01-17	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Quinoline derivative for treatment of triple-negative breast cancer
WO2019216395A1 (en) *	2018-05-11	2019-11-14	千寿製薬株式会社	Ophthalmic composition
CN110934816B (en) *	2018-09-25	2022-04-08	沈阳兴齐眼科医院有限公司	A kind of method for improving the stability of low-concentration atropine ophthalmic preparation
WO2020219707A1 (en) *	2019-04-24	2020-10-29	Allergan, Inc.	Compositions and methods for treatment of ocular conditions
WO2021001806A1 (en) *	2019-07-04	2021-01-07	Ocular Discovery Ltd.	Stable dipyridamole formulations with reduced impurities
CN115038414A (en)	2019-12-11	2022-09-09	艾诺维亚股份有限公司	System and device for delivering fluid to an eye and method of use
JP2023505841A (en) *	2019-12-16	2023-02-13	シドネキシス，インク．	Ophthalmic composition containing D2O
CN110917133A (en) *	2019-12-23	2020-03-27	河北科技大学	A kind of eye drops for treating myopia and preparation method thereof
WO2021226153A1 (en) *	2020-05-05	2021-11-11	The Procter & Gamble Company	Oral care compositions comprising dicarboxylic acid
CN111821259A (en) *	2020-07-14	2020-10-27	艾尔健康眼药(辽宁)有限公司	An ophthalmic pharmaceutical composition
CN111840221A (en) *	2020-08-25	2020-10-30	安徽博诺美科生物医药有限公司	Atropine sulfate eye drops
WO2022130033A1 (en) *	2020-12-17	2022-06-23	Sun Pharmaceutical Industries Limited	An aqueous sterile solution of atropine for ophthalmic use
EP4308080A4 (en) *	2021-03-16	2025-02-26	Vyluma Inc.	MULTI-DOSE CONTAINER FOR OPHTHALMIC COMPOSITIONS
EP4088714A1 (en)	2021-05-10	2022-11-16	Warszawskie Zaklady Farmaceutyczne Polfa S.A.	Ophthalmic pharmaceutical composition comprising atropine
EP4088713A1 (en)	2021-05-10	2022-11-16	Warszawskie Zaklady Farmaceutyczne Polfa S.A.	Ophthalmic pharmaceutical composition comprising atropine
CN113440486B (en) *	2021-06-02	2022-12-20	苏州欧康维视生物科技有限公司	An eye drop composition for preventing or treating ophthalmic diseases, and its preparation method
CN117295491A (en) *	2021-09-13	2023-12-26	安徽欧普视方医药科技有限公司	Atropine eye drops and preparation method thereof
CN118541148A (en)	2021-11-10	2024-08-23	视觉治疗股份有限公司	Carbonyl choline preparation for enhancing anti-presbyopia effect
CN114129511A (en) *	2021-12-07	2022-03-04	河南润弘制药股份有限公司	Atropine sulfate injection with improved stability
WO2023152642A1 (en) *	2022-02-08	2023-08-17	Avaca Pharma Private Limited	Ophthalmic compositions and methods thereof
US20230277521A1 (en) *	2022-03-07	2023-09-07	Harrow Ip, Llc	Extended-release pharmaceutical compositions for treating eye conditions
CN114569551A (en) *	2022-03-21	2022-06-03	杭州赫尔斯科技有限公司	Atropine eye drops and preparation method thereof
WO2023201315A2 (en) *	2022-04-14	2023-10-19	TearClear Corp.	Ophthalmic agent in preservative removal device
CN115177584A (en) *	2022-07-14	2022-10-14	成都市海通药业有限公司	Preparation method of atropine sulfate injection
WO2024091789A1 (en) *	2022-10-26	2024-05-02	Vyluma Inc.	Childhood atropine for myopia progression
CN115998692A (en) *	2023-02-15	2023-04-25	苏州欧康维视生物科技有限公司	Atropine drug product and application thereof
WO2025146828A1 (en) *	2024-01-05	2025-07-10	ロート製薬株式会社	Ophthalmic composition

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WO2016172712A2 (en) *	2015-04-23	2016-10-27	Sydnexis, Inc.	Ophthalmic composition

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2018
- 2018-05-10 MX MX2019013218A patent/MX392558B/en unknown
- 2018-05-10 PL PL18798073T patent/PL3548000T3/en unknown
- 2018-05-10 SI SI201830521T patent/SI3548000T1/en unknown
- 2018-05-10 WO PCT/US2018/032017 patent/WO2018209051A1/en not_active Ceased
- 2018-05-10 EP EP18798073.5A patent/EP3548000B1/en active Active
- 2018-05-10 ES ES18798073T patent/ES2901140T3/en active Active
- 2018-05-10 PT PT187980735T patent/PT3548000T/en unknown
- 2018-05-10 US US15/976,279 patent/US10251875B2/en active Active
- 2018-05-10 JP JP2018091739A patent/JP6557379B2/en active Active
- 2018-05-10 EP EP21205568.5A patent/EP3970694A1/en active Pending
- 2018-05-10 CN CN201880031247.6A patent/CN110621298B/en active Active
- 2018-05-10 LT LTEPPCT/US2018/032017T patent/LT3548000T/en unknown
- 2018-05-10 HR HRP20212019TT patent/HRP20212019T1/en unknown
- 2018-05-10 CA CA3063228A patent/CA3063228C/en active Active
- 2018-05-10 KR KR1020197036249A patent/KR102281667B1/en active Active
- 2018-05-10 RS RS20211580A patent/RS62817B1/en unknown
- 2018-05-10 RU RU2019139290A patent/RU2745603C1/en active
- 2018-05-10 AU AU2018265257A patent/AU2018265257B2/en active Active
- 2018-05-10 SG SG11201910085U patent/SG11201910085UA/en unknown
- 2018-05-10 HU HUE18798073A patent/HUE056595T2/en unknown
2019
- 2019-02-20 US US16/280,585 patent/US10610525B2/en active Active
- 2019-02-20 US US16/280,552 patent/US11071732B2/en active Active
- 2019-02-20 US US16/280,405 patent/US10583132B2/en active Active
- 2019-02-20 US US16/280,384 patent/US10568875B2/en active Active
- 2019-02-20 US US16/280,669 patent/US10576074B2/en not_active Ceased
- 2019-07-11 JP JP2019129403A patent/JP6681502B2/en active Active
- 2019-07-11 JP JP2019129396A patent/JP6865476B2/en active Active
- 2019-07-11 JP JP2019129405A patent/JP6681503B2/en active Active
- 2019-11-11 CL CL2019003228A patent/CL2019003228A1/en unknown
- 2019-11-18 CO CONC2019/0012893A patent/CO2019012893A2/en unknown
- 2019-11-28 PH PH12019502701A patent/PH12019502701A1/en unknown
2020
- 2020-07-20 US US16/933,642 patent/US11464769B2/en active Active
- 2020-08-31 US US17/007,816 patent/US11730727B2/en active Active
- 2020-08-31 US US17/007,900 patent/US11730728B2/en active Active
- 2020-09-09 US US17/016,186 patent/US11707458B2/en active Active
2021
- 2021-01-11 US US17/145,589 patent/US11642338B2/en active Active
- 2021-03-30 JP JP2021056894A patent/JP7332179B2/en active Active
- 2021-12-23 CY CY20211101132T patent/CY1124880T1/en unknown
2022
- 2022-03-02 US US17/685,286 patent/USRE50040E1/en active Active
2023
- 2023-06-28 US US18/343,636 patent/US12036217B2/en active Active
2024
- 2024-06-26 US US18/755,212 patent/US20240342154A1/en active Pending

Patent Citations (2)

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Publication number	Priority date	Publication date	Assignee	Title
US20160009705A1 (en) *	2014-06-24	2016-01-14	Sydnexis, Inc.	Ophthalmic composition
WO2016172712A2 (en) *	2015-04-23	2016-10-27	Sydnexis, Inc.	Ophthalmic composition

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